
Braive
|Trust CentreBraive is built for both sides of the clinical mental health relationship: the clinician and the patient in one shared journey. This makes genuine mental health outcomes tracking, compliance, and scalability possible.
Compliance Frameworks
Frameworks
ISO 13485
Medical Device
Quality Management

ISO 13485:2016 Quality Management System (QMS) for medical devices
Braive AB - EN ISO 13485 Certificate
Braive AB's EN ISO 13485 Certificate, issued by TÛV NORD Scandinavia Medical Notified Body AB on 20 February 2026.EU MDR (Class IIa)
EUEEA
EU Medical Device Regulation (Class IIa)
Braive AB - EU Class IIa Device Certificate
GDPR
Data Protection
EUEEA
General Data Protection Regulation